Minaxi Kumari

Senior Drug Safety Lead & Literature SME with 6.5+ years of experience in high-volume Pharmacovigilance (PV) operations and Quality Control (QC). Proven leadership in managing cross-functional teams to process 11,900+ ICSRs with 100% regulatory compliance. Expert in Argus and ARISg safety databases, specializing in complex literature case management, MedDRA/WHO Drug coding, and reconciliation.

Former Local Safety

Officer (LSO) for Singapore and the Philippines, skilled in compliance monitoring, CAPA management, and regulatory reporting. Adept at transforming quality data into actionable insights and mentoring teams to exceed global safety standards. Clinical trials, CDM experience, sponsor management and team handling experience.

Operations Specialist 1 - IQVIA - Mumbai, India

(2023-06 - 2025-03)

• Managed the initial triage process and prioritization of all incoming safety reports while conducting systematic duplicate searches across local and global safety databases to ensure data integrity.
• Served as the Subject Matter Expert (SME) for literature surveillance, overseeing case screening, generation, and weekly and biannual reviews.
• Evaluated Individual Case Safety Reports (ICSRs) from all data sources to verify validity, seriousness, causality, and expectedness while ensuring precise MedDRA coding and labelling.
• Analyzed clinical trial data for dechallenge and rechallenge outcomes and identified clinically relevant information for signal detection to monitor potential safety issues.
• Collaborated with Medical Reviewers to resolve complex clinical queries and finalize causality assessments for safety cases.
• Executed targeted case follow-ups to capture missing information and ensure comprehensive data integrity across the safety database.
• Oversaw global submissions of Suspected Unexpected Serious Adverse Reactions (SUSARs) and expedited reports to Health Authorities and trial sites, performing final Quality Control (QC) before submission.
• Managed daily, weekly, and monthly reconciliations with vendors to ensure global compliance and data alignment.
• Performed rigorous Quality Reviews (QC) of ICSRs and team outputs to ensure strict adherence to established safety plans and regulatory requirements.
• Prepared deviation memos, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPAs) to address compliance gaps and drive process improvement.
• Actively participated in audits and inspections by providing technical support and documentation to ensure regulatory readiness.
• Authored and reviewed Standard Operating Procedures (SOPs) and relevant safety guidance documents to standardize departmental workflows.
• Headed vendor management and training initiatives to ensure external partners maintained operational standards.
• Led the onboarding, mentoring, and query management for new team members, including performing QC of their initial work to ensure quality.
• Developed monthly quality metric reports and presented daily strategic updates during team meetings to monitor performance.
• Worked in different time zones effectively.
• SME for Literature Screening and Biannual reviews.
• Handled a Huge bolus project of 12000 cases with 100% compliance and delivered within timelines

Senior Drug Safety Specialist - Johnson and Johnson - Gurgaon, India

(2018-08 - 2024-05)

Management of Queries of team and training/mentoring of new hires. Responsible for Follow ups and health Authority submissions for ICSR. Managed the initial triage process and prioritization of all incoming safety reports.

Conducted systematic duplicate searches in both local tracking systems and global safety databases to ensure data integrity. Served as the Subject Matter Expert (SME) for weekly and biannual literature reviews, including case screening and generation. Reviewed ICSRs to verify case validity, seriousness, causality, and expectedness.

Ensured accurate MedDRA coding and assessed ADR seriousness and labeling. Evaluated clinical trial cases for DE challenge/rechallenge outcomes and identified clinically relevant data for signal detection. Collaborated with medical reviewers to resolve complex clinical queries and causality assessments.

Executed targeted case follow-ups to obtain missing information and ensure complete data entry. Managed the submission of SUSARs and expedited reports to Health Authorities and trial sites per IB and PI requirements. Handled daily, weekly, and monthly reconciliation with vendors to ensure compliance and data alignment.

Processed case del

• Strategic Project Leadership: Currently spearheading the Bolus Project Management Plan, co-leading high-volume "Bolus" projects with more than 400000 data, and overseeing the end-to-end lifecycle of safety data surges.
• Quality Control (QC) & Compliance: Conducted rigorous Quality Checks of Individual Case Safety Reports (ICSR) across all types: Solicited, Spontaneous, Clinical Trial (CT), and Literature cases.
• Market-Specific SME: Managed all End-to-End PV activities in cross Sector, ensuring 100% compliance with local health authority regulations and global reporting timelines.
• Literature Surveillance: Served as the SME for Literature Search and Review, identifying potential safety signals and documenting cases in accordance with GVP Module VI.
• Team Development & Training: Lead training initiatives for new team members and external vendors; manage ongoing reconciliation efforts to ensure data integrity across vendor-led projects.
• Operational Back-up & Leadership: Delegated as a critical back-up for the IPV Case Management Team Lead, maintaining operational continuity and providing oversight for a cross-functional collaboration network.

Bachelor Degree - Pharmacy - Himachal Pradesh University Shimla (2010 - 2014)

Summer Training - Industrial Training - INDOCO Pharmaceuticals Pvt Ltd. (2009-05-25 - 2009-06-25)

MS/M.Sc(Science) - Clinical Research and Pharmacovigilance - Punjab Technical University (PTU) (2014 - 2016)